Z-0064-2015Class III

Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a...

Name: Z-0064-2015 Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a...
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-09-12
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-09-12 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Operations, Inc. began a recall of Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to... on 2014-09-12. FDA classified it as Class III and gives the reason as "The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0064-2015
Classification: Class III
Status: Terminated
Initiated: 2014-09-12
Posted: 2014-10-10
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
Product: Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. Consignees are instructed as follows: " Check the current set of reference values on your cobas b 221 blood gas system and, if appropriate, change the reference ranges accordingly. " If you have not established your own reference ranges, please follow the instructions in the Workaround section of the UMDC or contact the Roche Support Network Customer Support Center.
Quantity in commerce: 492 devicees
Distribution: Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI.
Product codes and lots: Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0064-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0064-2015	Class III	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-10

Product code CHL

K032311Class IIRoche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. / cleared 2003-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)